FDA Product Code QTW: Digital Amsler Grid
A Digital Amsler Grid Is Intended As An Aid In Detection Of Central Visual Irregularities Caused By Changes In The Visual Pathway In Patients.
Leading manufacturers include Neuro-Eye Diagnostic Systems, LLC.
1
Total
1
Cleared
637d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Digital Amsler Grid Devices (Product Code QTW)
1 devices
About Product Code QTW - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QTW since 2022, with 1 receiving FDA clearance (average review time: 637 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.